Novavax Seeks EUA Approval Of Its COVID-19 Vaccine In PH — FDA

Novavax sought an EUA approval of its COVID-19 vaccine in the Philippines, according to FDA.

On Friday, the Food and Drug Administration (FDA) said that American drugmaker Novavax had filed an application for emergency use authorization (EUA) of its COVID-19 vaccine in the Philippines.

Novavax sought an EUA approval of its COVID-19 vaccine in the Philippines, according to FDA.
Photo source: Gavi

FDA Director-General Eric Domingo told GMA News Online in a text message that Novavax applied for EUA but their requirements weren’t yet complete.

Earlier, Domingo said the Novavax COVID-19 vaccine was “very promising” and performed well even against the Delta COVID-19 variant. If approved, the said vaccine would be the eighth vaccine to become available for emergency use in the Philippines.

Novavax also said that its protein-based COVID-19 vaccine showed 93% effectiveness against Alpha, Beta, and Gamma COVID-19 variants. The said vaccine, which was manufactured in India, was found to be 100% effective in preventing moderate and severe coronavirus infection.

According to Novavax, a single booster shot of its COVID-19 vaccine given six months after an initial two-dose vaccine elicited a 4.6-fold increase in antibodies.

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The Philippines officially signed a supply agreement for 30 million Novavax COVID-19 vaccine doses last March.

GMA News Online reported that the Indian ambassador to the Philippines had previously said that the Novavax COVID-19 vaccine doses would arrive in the Philippines in the “third or fourth quarter of the year”. However, Reuters reported that Novavax had been struggling to access the raw materials and equipment needed in order to produce its COVID-19 vaccine.

Rappler reported that Cavite Governor Jonvic Remulla said last July that he expected the arrival of 1.5 million Novavax COVID-19 vaccine doses by the “third week of August or first week of September”.

Meanwhile, the Philippine ambassador to Washington had said that Novavax was among the companies interested in putting up a vaccine manufacturing plant in the Philippines.

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